Associate Director, Quality Assurance – Sterile / Radiopharmaceutical Manufacturing
Location: Not specified
Posted: 1 week ago
Pay Range: $150,000.00/yr - $180,000.00/yr
We're supporting a growing pharmaceutical manufacturer with a highly specialized platform, seeking an Associate Director of Quality Assurance to drive GMP compliance, QA systems strategy, and inspection readiness across complex manufacturing operations.
This is a standout opportunity for QA leaders with experience in sterile injectables, radiolabeled products, or time-sensitive GMP manufacturing environments.
Key Responsibilities:
- Oversee QA operations across manufacturing, packaging, and batch record review
- Lead investigations, root cause analyses, CAPAs, and change control processes
- Manage QA support for radiolabeling or aseptic operations (as applicable)
- Review and approve critical quality documentation (SOPs, protocols, reports)
- Represent QA during regulatory inspections and internal/external audits
- Develop team capabilities, manage department resourcing, and own quality KPIs
Ideal Background:
- Bachelor's degree in a scientific discipline
- 6+ years in QA/QC within GMP-regulated pharma or biotech environments
- 3+ years in a leadership role, with oversight of QA operations or systems
- Familiarity with radiopharmaceuticals, sterile injectables, or short-shelf-life products is highly desirable
- Experience with aseptic processing, batch release, and regulatory agency engagement
Why Join?
- Competitive compensation and bonus eligibility
- Full medical, dental, and vision benefits with employer contributions
- 401(k) with company match
- Paid time off, holidays, and company-sponsored life and disability insurance
- Strong training programs and professional growth opportunities
This is an opportunity to lead QA strategy at a highly dynamic, regulated site—ideal for those with radiopharma or sterile manufacturing experience looking to take the next step.
Contact: Phone/text: 617-###-####
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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